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VIIV Company Profile

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What is the competitive landscape for VIIV, and when can generic versions of VIIV drugs launch?

VIIV has nineteen approved drugs.

There are seventeen US patents protecting VIIV drugs.

Summary for VIIV

US Patents:	17
Tradenames:	12
Ingredients:	12
NDAs:	19
Patent Litigation for VIIV:	See patent lawsuits for VIIV
PTAB Cases with VIIV as patent owner:	See PTAB cases with VIIV as patent owner

Drugs and US Patents for VIIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		RX	Yes	No
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	9,242,986		Y	Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes	9,242,986		Y	Y
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-001	Apr 4, 1997		RX	Yes	No

Expired US Patents for VIIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,837,208
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,833,130*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	5,047,407*PED
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,818,538
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	4,837,208

Paragraph IV (Patent) Challenges for VIIV drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	150 mg and 300 mg		2007-10-16
	Tablets	150 mg and 300 mg		2011-08-08
	Oral Solution	20 mg/ml		2012-12-27
	Tablets	150 mg/300 mg		2007-06-26
	Tablets	10 mg, 25 mg and 50 mg		2017-08-14
	Tablets	300 mg/150 mg/300 mg		2011-03-22
	Oral Solution	10 mg/mL		2011-11-22
	Tablets	300 mg		2009-01-28
	Tablets	700 mg		2012-01-18
	Tablets	600 mg/300 mg		2007-09-27
	Tablets	600 mg/50 mg/300 mg		2017-08-14

International Patents for VIIV Drugs

Country	Document Number	Estimated Expiration
Costa Rica	9032
World Intellectual Property Organization (WIPO)	9842321
Japan	5131689
Yugoslavia	3401
Poland	194558

Supplementary Protection Certificates for VIIV Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012000038	Germany		PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
C/GB12/022	United Kingdom		PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111130
C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
7	Finland

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Viiv Hlthcare